Penicillin G Potassium Tablets
»Penicillin G Potassium Tablets contain not less than 90.0percent and not more than 120.0percent of the labeled number of Penicillin G Units.
Packaging and storage— Preserve in tight containers.
Identification— Shake a quantity of ground Tablet powder,equivalent to about 100,000Penicillin G Units,with 8mLof a solvent mixture consisting of acetone,0.1Mcitric acid,and 0.1Msodium citrate (2:1:1),and filter:the filtrate so obtained responds to the Identificationtest under Penicillin G Potassium for Injection.
Dissolution á711ñ—
Medium: pH6.0phosphate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions);900mL.
Apparatus 2: 75rpm.
Time: 60minutes.
Standard preparation— Dissolve an accurately weighed quantity of USP Penicillin G Potassium RSin Dissolution Medium,and dilute quantitatively with the same solvent to obtain a solution having a known concentration of about 400Penicillin G Units per mL.
Procedure— Filter the solution under test,dilute with Dissolution Medium,if necessary,and proceed as directed for Procedurein the section Antibiotics—Hydroxylamine Assay,under Automated Methods of Analysis á16ñ.Calculate the number of Penicillin G Units in each mLof the solution taken by the formula:
C(AU/AS),
in which Cis the concentration,in Penicillin G Units per mL,of the Standard preparation.
Tolerances— Not less than 70%(Q)of the labeled amount of Penicillin G Units is dissolved in 60minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Loss on drying á731ñ— Dry about 100mg,accurately weighed,of powdered Tablets in a capillary-stoppered bottle in vacuum at 60for 3hours:it loses not more than 1.0%of its weight.
Assay—
Standard preparation— Prepare as directed for Standard preparationunder Iodometric Assay—Antibiotics á425ñ,using USP Penicillin G Potassium RS.
Assay preparation— Place not less than 5Tablets in a high-speed glass blender jar containing an accurately measured volume of Buffer No.1,and blend for 4±1minutes.Dilute an accurately measured volume of this stock solution quantitatively with Buffer No.1to obtain an Assay preparationcontaining about 2000Penicillin G Units per mL.Pipet 2mLof this solution into each of two glass-stoppered,125-mLconical flasks.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ.Calculate the quantity,in Penicillin G Units in each Tablet taken by the formula:
(L/2D)(F)(B-I),
in which Lis the labeled quantity,in Penicillin G Units,in each Tablet,and Dis the concentration,in Units per mL,of Penicillin Gin the Assay preparationon the basis of the labeled quantity in each Tablet and the extent of dilution.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1489
Phone Number:1-301-816-8335